The Treatment of Lenalidomide in Patients With POEMS Syndrome
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Istituto Clinico Humanitas.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Istituto Clinico Humanitas
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00971685
First received: September 3, 2009
Last updated: September 1, 2010
Last verified: September 2010
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Purpose
Lenalidomide is a immunomodulatory drug derived from thalidomide, without neurotoxicity. Lenalidomide blocks the increased secretion of interleukin-6, tumor necrosis factor alpha and vascular endothelial growth factor (VEGF). The association with dexamethasone increased Lenalidomide response rate.
More recently the efficacy of Lenalidomide has been reported in a patient with POEMS (POEMS:polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome with improvement of clinical condition and reduction of vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6) level.
| Condition | Intervention | Phase |
|---|---|---|
|
POEMS Syndrome |
Drug: Lenalidomide and dexamethasone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Lenalidomide
U.S. FDA Resources
Further study details as provided by Istituto Clinico Humanitas:
Primary Outcome Measures:
- Evaluation of clinical efficacy of Lenalidomide for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg)) in patients with POEMS syndrome after 6 cycles. [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluation of the safety and the activity. [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 16 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2011 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lenalidomide plus Dexamethasone
RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg).
|
Drug: Lenalidomide and dexamethasone
RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with a diagnosis of POEMS syndrome based on published diagnostic criteria
Exclusion Criteria:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971685
Contacts
| Contact: Armando Santoro, MD | +39028224 ext 4080 | armando.santoro@humanitas.it |
| Contact: Andrea Nozza, MD | +39028224 ext 4080 | andrea.nozza@humanitas.it |
Locations
| Italy | |
| Istituto Clinco Humanitas | Recruiting |
| Rozzano, Milano, Italy, 20089 | |
| Contact: Andrea Nozza, MD +39028224 ext 4080 andrea.nozza@humanitas.it | |
| Sub-Investigator: Andrea Nozza, MD | |
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
| Principal Investigator: | Armando Santoro, MD | Istituto Clinico Humanitas |
More Information
No publications provided
| Responsible Party: | Armando Santoro, MD, Istituto Clinico Humanitas |
| ClinicalTrials.gov Identifier: | NCT00971685 History of Changes |
| Other Study ID Numbers: | ONC-2008-002 |
| Study First Received: | September 3, 2009 |
| Last Updated: | September 1, 2010 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
POEMS Syndrome Polyneuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Abnormalities, Multiple Congenital Abnormalities Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate |
Lenalidomide Thalidomide BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 21, 2013